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Outlook 2007

Published by: Informa Healthcare

Published: Dec. 1, 2006 - 58 Pages


Table of Contents


CHAPTER 1 INTRODUCTION TO BIOPROCESSING
1.1 Introduction
1.1.1 Special considerations
1.2 The biopharmaceutical development process
1.2.1 Drug discovery
1.2.2 Process development
1.2.3 Clinical Trials
1.2.4 Time-to-market
1.3 The biopharmaceutical manufacturing process
1.3.1 Manufacturing capacity
1.3.2 Scale-up of production processes
1.4 Demand for biologics
1.4.1 Historical growth
1.4.2 Biologics in clinical trials
1.4.3 Approved biological products
1.5 Contract manufacturing organisations
1.5.1 Clinical Trials Directive
1.5.2 CMO Entrant
CHAPTER 2 GROWTH OPERATIONS
2.1 EXPRESSION SYSTEMS
2.1.1 Host organisms
2.1.2 Transgenic hosts
2.2 Culture type
2.2.1 Suspension culture
2.2.2 Attachment dependent
2.3 Growth characterisitics
2.3.1 Product formation
2.3.2 Scale-up
2.3.3 Culture media
2.3.4 Process monitoring and control
2.4 Modes of operation
2.4.1 Batch operation
2.4.2 Fed-batch operation
2.4.3 Media exchange operation
2.4.4 Perfusion operation
2.4.5 Solera
CHAPTER 3 RECOVERY & DOWNSTREAMS PROCESSING
3.1 Recovery
3.1.1 Centrifugation
3.1.2 Lysis
3.1.3 Filtration
3.2 Purification
3.2.1 Solubilisation and refolding
3.2.2 Chromatography
3.2.3 Precipitation
3.2.4 Viral clearance
3.3 Sterile filtration
3.4 Formulation, fill and finish
3.4.1 Pre-formulation
3.4.2 Stabilisation and formulation
3.4.3 Fill finish operations
CHAPTER 4 SUPPORT OPERATIONS
4.1 Process equipment
4.1.1 Standard vessels
4.1.2 Jacketed vessels
4.1.3 Disposables
4.1.4 Pipework
4.1.5 Manifolds
4.2 Process solutions and waste
4.2.1 Process solutions
4.2.2 Sampling
4.2.3 Waste
4.3 Cleaning and sterilisation
4.3.1 Clean-in-place (CIP)
4.3.2 Sterilisation
4.4 Process utilities
4.4.1 Purified water (PW)
4.4.2 Water for injection (WFI)
4.4.3 Clean steam
4.4.4 Utility distribution
CHAPTER 5 BIOPROCESS DESIGN
5.1 Introduction
5.2 Bioprocess design
5.2.1 Process description
5.2.2 GMP philosophy
5.2.3 Mass balance
5.2.4 Block flow diagrams and process flowsheets
5.2.5 Process Simulation
5.2.6 Equipment List
5.2.7 Piping and instrumentation diagram
5.2.8 Process control
5.2.9 Scale-up/Scale-down
5.3 Facility design
5.3.1 Facility products
5.3.2 Plant layout
5.3.3 Room classifications and HVAC zoning
5.3.4 Clean air
5.3.5 People, material and waste flows
5.3.6 Change rooms and airlocks
5.3.7 Waste management
5.4 Design lifecycle
5.4.1 Conceptual design
5.4.2 Front end engineering
5.4.3 Detail design
5.4.4 Construction
5.4.5 Commissioning and qualification
CHAPTER 6 PROCESS SIMULATION
6.1 Introduction
6.1.1 Simulation models
6.1.2 Simulation study
6.2 Overview of process simulation
6.2.1 Challenges of bioprocess simulation
6.2.2 Benefits of process simulation
6.2.3 Simulators for the bioprocess industry
6.3 Bioprocess simulation
6.3.1 Domain description
6.3.2 Modelling scope of a bioprocess simulator
6.3.3 Bioprocess simulation software packages
6.4 A simulation case study
6.4.1 An example of a modelling framework
6.4.2 Case study set-up
6.4.3 Simulation results and discussion
6.4.4 Conclusion
CHAPTER 7 COST MODELLING
7.1 Introduction
7.2 Cost performance metrics
7.2.1 Capital costs
7.2.2 Operating costs
7.2.3 Net Present Value (NPV)
7.3 Framework of a cost model
7.3.1 An example of a cost model framework
7.3.2 Data collection
7.3.3 COG modules
7.4 A COG case study
7.4.1 Case study set-up
7.4.2 Simulation results and discussion
CHAPTER 8 SAMPLE PROCESSES
8.1 Therapeutic proteins
8.1.1 Monoclonal antibodies (MAbs)
8.1.2 Recombinant interferons
8.1.3 Recombinant interleukins
8.1.4 Recombinant hormones
8.1.5 Recombinant growth factors
8.1.6 Monoclonal antibodies
8.1.7 Growth
8.1.8 Recovery
8.1.9 Purification
8.2 Vaccines
8.2.1 Types of vaccines
8.2.2 Whooping cough
8.2.3 Growth and Recovery
8.2.4 Solid Fraction Lysis and Purification
8.2.5 Supernatant Purification
8.2.6 Polishing and combined purification
8.3 Gene therapy
8.3.1 Genetic Vectors
8.3.2 Growth
8.3.3 Recovery
8.3.4 Purification
8.4 Cellular therapy
8.4.1 Dendritic white blood cells
8.4.2 Purification & transformation
8.4.3 Recovery and Growth
CHAPTER 9 DISPOSABLES
9.1 Disposable application evaluation
9.1.1 Quantitative analysis
9.1.2 Benefits of disposable technology
9.1.3 Disadvantages of disposable technology
9.2 Design guide: bag handling
9.2.1 Empty bioprocess bags & disposable equipment
9.2.2 Filled bioprocess bags
9.2.3 Tubing
9.3 Systems
9.3.1 Cell culture
9.3.2 Chromatography
9.3.3 Mixer systems
9.3.4 Freezing systems
9.4 Components
9.4.1 Bags
9.4.2 Connectors
9.4.3 Rapid transfer ports
9.4.4 Tubing
9.4.5 Filling
9.5 Instrumentation and control
CHAPTER 10 REGULATORY ENVIRONMENT
10.1 Product licensing
10.1.1 Clinical development and product approval
10.1.2 Clinical trials
10.1.3 Regulatory authorities
10.2 Good manufacturing practice
10.2.1 Defining the regulatory requirements
10.2.2 Regulatory framework
10.2.3 Scope Process areas
10.2.4 Assessing requirements
10.2.5 Design considerations
10.2.6 Viral clearance of biotechnology products
10.2.7 Good Automated Manufacturing Practices (GAMPs)
10.3 Biosafety
10.3.1 Defining the regulatory requirements
10.3.2 Risk
10.3.3 Biosafety & GMP
10.4 Validation approach
10.4.1 Validation requirements
10.4.2 Validation life cycle
10.5 Quality: The role of QA/QC
10.5.1 Quality Assurance
10.5.2 Quality Control
LIST OF TABLES
Table 1.1 Average figures for number of subjects, success rates and trial durations in clinical phases
Table 1.2 Mean total phase lengths for biopharmaceuticals
Table 1.3 Typical dosage figures for a selection of approved products
Table 1.4 Typical therapeutic antibodies approved, and their indications
Table 4.1 Typical mixing time for media and buffer preparation
Table 4.2 System requirements for solution preparation stations
Table 5.1 Environmental classification
Table 5.2 Classification of cleanrooms
Table 6.1 Comparison of SuperPro/SchedulePro Designer and BPS Simulation
Table 6.2 Major equipment specification
Table 7.1 A typical worksheet for presenting the annual cash flow, the discounted present value and the net present value of a project.
Table 7.2 An example of a production worksheet
Table 7.3 An example of an equipment list worksheet
Table 7.4 Cost factors included in the capital charge
Table 7.5 Lang factors used in the capital estimate (contingencies excluded)
Table 7.6 Labour benchmarking factors and estimated headcount
Table 7.7 Capital breakdown for the traditional and concept facility
Table 7.8 Cost of goods (COG) comparison (including capital) (€/g)
Table 9.1 Tubing pass-through options
Table 9.2 Disposable bioreactors
Table 9.3 Disposable flasks, bottles and other containers
Table 9.4 Mixer systems
Table 9.5 Disposable connectors
Table 9.6 Instrumentation and control components
Table 10.1 Average figures for number of subjects, success rates and trial durations in clinical phases
Table 10.2 Regulatory bodies
Table 10.3 ICH documents
Table 10.4 EU Directives and Guidelines
Table 10.5 US Regulations and Guidelines
Table 10.6 System Classifications


Abstract

This report takes a look at what we think will happen in 2007, eg who will be the companies to watch, where the key new drugs will come from, the new regulations that are going to come into force next year and their impact, etc. It will give companies an overview of the year to come and help them plan their business strategy for 2007.

Pharma companies, consultants and financiers want to know what is in store for the year to come. This report, compiled by Peter Rixon, but with contributions from the editors of all the major titles reveals what we think will happen in the year to come. With chapters on the pharma market, generics, patent expiries and legal action, and regulation, it looks at each aspect in the market in detail and explores the potential developments in each area. All chapters are backed up by charts, tables and other key statistics, making it an essential companion for the industry in the year to come.


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